Transport and Metabolism of L-arginine: Role for Endothelial Dysfunction in Essential Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- meaning of L-arginine transport and metabolism on endothelial function
研究概览
简要总结
Essential hypertension is characterized by impaired endothelial function. Data derived from normotensive subjects with a genetic predisposition to arterial hypertension suggest that endothelial dysfunction is a cause rather than a consequence of the condition. Given that, in normotensive offspring of hypertensive parents, impaired endothelium dependent vasodilation can be restored by supplementation of the nitric oxide (NO) precursor L-arginine, a defect in the L-arginine/NO pathway can be postulated. The investigators at the University of Erlangen-Nuremberg, hypothesize that impaired endothelial function in essential hypertension is associated with alterations in L-arginine metabolism and transport. This study will determine whether metabolism and transport of L-arginine are altered in patients with essential hypertension and whether these potential alterations can be targeted therapeutically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males, ages 18-65
- •Male and female healthy control subjects ages 18-65
排除标准
- •Any other coexisting condition
- •Advanced damage of vital organs (grade III und IV retinopathy)
- •Therapy with a not approved concomitant medication in the last 4 weeks prior to intake of the first trial medication, especially lipid lowering and antidiabetic medications (washout phase)
- •Blood donation within the last 4 weeks
- •Patients with arterial fibrillation or atrioventricular (AV)-block (II and more)
- •Patients with anamnestic myocardial infarct
- •Patients with depression
- •Patients with seizure disorders
- •Patients with unstable angina pectoris including electrocardiogram (ECG)-aberrations or cardiac insufficiency New York Heart Association (NYHA) Stadium III and IV
- •History of a malignant illness with the exception of those patients who have recovered for more than 10 years or have a basalioma of the skin.
- •Actual or anamnestic alcohol or drug abuse
- •History of organ transplant
- •Anaphylaxis or known therapy resistance to any of the used test matters.
- •Therapy with a not approved concomitant therapy
- •Participation in another study within three months prior to study inclusion
- •Illnesses, which can influence the pharmacodynamics or pharmacokinetics of the test substance
- •Liver or kidney diseases: SGOT, GPT , γ-GT, AP, bilirubin and creatinine above 200% of standard
- •Patients who are not sufficiently compliant; or patients who are not capable or willing to appear for controlling visits.
- •Severe or unstable medical or psychiatric illnesses, which will, in the estimation of the examiner, endanger the safety of the proband or the successful participation in the study
- •Presumed risk of transmission of HIV or hepatitis via blood from the proband
结局指标
主要结局
meaning of L-arginine transport and metabolism on endothelial function
时间窗: 4 weeks
次要结局
未报告次要终点